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FDA 510(k)

QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00

K-Number: K013531 · 2001-11-07

ApplicantImpac Medical Systems, Inc.
Decision Date2001-11-07
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 is the device name listed in this FDA 510(k) record. The listed applicant is Impac Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-11-07 under 510(k) number K013531. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00?

QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 is a medical device that received FDA 510(k) clearance on 2001-11-07. The listed applicant is Impac Medical Systems, Inc.. The 510(k) number is K013531.

When did QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 receive FDA 510(k) clearance?

QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 received FDA 510(k) clearance on 2001-11-07, under 510(k) number K013531.

Who is the listed applicant for QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00?

The FDA 510(k) record lists Impac Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00?

The FDA product code for QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 is KPQ.

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Other records listing Impac Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132971MONACOK123230MOSAIQ ONCOLOGY INFORMATION SYSTEMK120067MOSAIQ ONCOLOGY INFORMATION SYSTEMK043412MODIFICATION TO: VIEWSTATIONK011694VIEWSTATIONK991133MLC FIT

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Related Devices (Code: KPQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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